CN101484083B - For ablating biological tissues of a catheter-based system and method for RF - Google Patents

For ablating biological tissues of a catheter-based system and method for RF Download PDF

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CN101484083B
CN101484083B CN 200780024951 CN200780024951A CN101484083B CN 101484083 B CN101484083 B CN 101484083B CN 200780024951 CN200780024951 CN 200780024951 CN 200780024951 A CN200780024951 A CN 200780024951A CN 101484083 B CN101484083 B CN 101484083B
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rf
temperature
module
ratio
signal
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CN101484083A (en
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乔治·L·梁
朱彼得
沈国镇
罗铭勋
西奥多·C·奥士比
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麦迪威公司
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B18/1492Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/1815Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using microwaves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238Type of minimally invasive operation
    • A61B2017/00243Type of minimally invasive operation cardiac
    • A61B2017/00256Creating an electrical block
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003Steerable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00666Sensing and controlling the application of energy using a threshold value
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00666Sensing and controlling the application of energy using a threshold value
    • A61B2018/00678Sensing and controlling the application of energy using a threshold value upper
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00696Controlled or regulated parameters
    • A61B2018/00702Power or energy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00773Sensed parameters
    • A61B2018/00779Power or energy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00773Sensed parameters
    • A61B2018/00779Power or energy
    • A61B2018/00785Reflected power
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00773Sensed parameters
    • A61B2018/00791Temperature
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/0091Handpieces of the surgical instrument or device
    • A61B2018/00916Handpieces of the surgical instrument or device with means for switching or controlling the main function of the instrument or device
    • A61B2018/0094Types of switches or controllers
    • A61B2018/00946Types of switches or controllers slidable

Abstract

一种用于消融位于患者身体血管内的生物组织的基于射频的导管系统和方法,其包括射频(RF)发生器(616),以在具有RF传输线的可设置的导管(500)内选择性地产生高频RF能量信号,还包括安装在该导管远端部分的RF天线(250),以及同样安装在该导管远端部分的、用于检测消融点附近温度的温度传感器(520)。 An apparatus for ablating biological tissue located within a body vessel of a patient a catheter-based system and method for RF, which includes a radio frequency (RF) generator (616) for selectively within a catheter (500) may be provided having a RF transmission line generating a high frequency signal RF energy, the RF antenna further comprises mounting (250) of the catheter distal end portion, and a temperature sensor (520) for detecting a temperature near the ablation site is also mounted on the catheter distal end portion. 控制系统(610)调整RF能量信号以使得检测的温度等于或者接近选择的温度设定或者在选定温度范围内。 The control system (610) to adjust the RF energy signal such that the detected temperature is equal to or near the selected temperature setting, or within a selected temperature range.

Description

用于消融生物组织的基于射频的导管系统和方法 For ablating biological tissues of a catheter-based system and method for RF

技术领域 FIELD

[0001] 本发明涉及一种基于射频的导管系统,其使用RF天线产生的电场来消融组织和梗塞,尤其是消融在动物充液管腔内,例如人体心脏,肝脏,动脉和血管内的组织和梗塞,并且具体涉及一种基于预先设置的阈值级别来控制RF能量以对准生物组织的控制系统和方法。 [0001] The present invention relates to a catheter-based radio system, which uses an electric field generated by the RF antenna and ablated tissue infarction, especially filling the ablation lumen in an animal, such as human heart, liver, arteries and vascular tissue and infarction, and in particular based on a preset threshold level to control the RF energy to the alignment control system and method of biological tissue.

背景技术 Background technique

[0002] 近几年,作为心脏疾病和其它严重疾病的重要治疗形式,医疗设备已经在医学界得到认可,而传统上所述疾病是采用药物或外科手术治疗的。 [0002] In recent years, as an important treatment for heart disease and other serious forms of the disease, the medical device has been recognized in the medical community, and traditionally the disease is the use of a drug or surgical treatment. 在心脏疾病治疗上出现两种基本的趋势。 Two basic trends in the treatment of heart disease. 第一种是从心脏直视外科手术转变为较少介入和较便宜的基于导管的治疗, 它更安全并且消耗更少的精力。 The first is to look directly into the heart surgery from less intervention and less expensive catheter-based treatment, it is more secure and consume less energy.

[0003] 第二种趋势以从使用抗心律不齐药物转变为最低限度的导管介入或者其它基于设备的治疗以减轻无法治愈的心律不齐。 [0003] The second trend to the use of anti-arrhythmic drugs into a minimum of a catheter or other interventional device-based therapy to relieve incurable arrhythmias. 例如,自动心律转复除颤器通常被植入具有致命心室心律不齐的患者以降低突然死亡的危险。 For example, a cardioverter defibrillator implanted in patients are often fatal ventricular arrhythmias to reduce the risk of sudden death. 因此射频(在IOOkHz到IOMHz之间的次微波(sub-microwave)频率)导管消融现在很多患有心律不齐的患者中被采用。 Thus the radio frequency is employed in patients (in the sub-microwave (sub-microwave) frequencies between IOOkHz to IOMHz) catheter ablation is now a lot of suffering from arrhythmia.

[0004] 虽然在技术上有这些优势,心房颤动(“AF”)仍然是一个重要的挑战。 [0004] Despite these advantages in technology, atrial fibrillation ( "AF") remains an important challenge. AF,由于不均勻的电子脉冲引起的心脏心房或上心室快速的无规律的节律,代表了导致中风以及心脏病以及主要健康保健责任的重要原因。 AF, due to uneven electrical impulses cause the atria of the heart or the rhythm of rapid irregular ventricular, represents an important cause of stroke and heart disease as well as major health care responsibilities. 目前为止,治疗AF最有效的手术操作是在心脏直视手术下的Maze手术。 So far, the most effective surgical treatment of AF is operating under direct vision Maze surgery in heart surgery. 在Maze手术中,沿着心房外预定的线切口,然后缝合。 In the Maze procedure, the predetermined incision line along the outer atrium, and then sutured. 随着逐渐康复,沿着切口线形成伤痕,从而形成对于电子脉冲传导的阻隔。 With the gradual rehabilitation, scars are formed along the cut line, thereby forming a barrier for the conduction electron pulse. 通过建立这种阻隔,就不在保持AF维持并恢复了正常的心律。 Through the establishment of this barrier, it is not in keeping AF maintain and restore normal heart rhythm. 但是,由于包括开胸腔和切除胸骨的心脏直视手术的并发症以及相关的死亡率,Maze手术并没有被广泛采用。 However, due to the inclusion of the heart and chest cut open the sternum surgery complications and associated mortality, Maze surgery and has not been widely adopted.

[0005] 一种效仿Maze手术的新的方法是基于导管的射频消融技术,其中,不是采用外科切口,而是应用一个导管电极来消除或消融位于心房腔内的心脏组织。 [0005] The new method of operation is to follow Maze radiofrequency catheter ablation technique based, wherein, instead of using a surgical incision, a catheter electrode application but to eliminate or ablating cardiac tissue located atrial cavity. 和医学界惯例相同, 该导管电极经由动脉进入到达心房。 And the same medical practice, the catheter into the artery via the electrode reaches the atrium. 在心房内,通常借助于X射线或荧光镜装置来放置导管电极的末端,并将其带入并接触期望位置或要消融位置处的心脏组织。 The atrium, usually by means of X-ray or fluoroscopic means to place the electrode tip of the catheter, and brought it into contact with a desired position and for ablating cardiac tissue, or at the location. 在该位置,通过导管电极产生的电阻式加热消除该组织。 In this position, resistive heating generated by the catheter electrode to eliminate the organization. 之后,导管电极被重新放置在下一个消融位置。 Thereafter, the electrode catheter ablation is repositioned at the next position. 效仿如Maze手术所实现的对抗电子脉冲传导的线性损伤,从而实现了一系列位置消融。 Follow linear damage against electron conduction pulse Maze procedure as implemented, thereby achieving a series of positions ablation.

[0006] 可意识到现有的基于导管的消融手术比心脏直视手术具有更少的介入。 [0006] can be appreciated that a conventional catheter-based ablation procedures has less than open heart surgery intervention. 此外,在消融中,减少了心血管破坏。 In addition, the ablation, reducing cardiovascular damage. 但是,一个成功的基于导管的射频消融手术需要消融的组织点在相邻位置之间的空间上或者接近偏差通常少于2毫米,以防止电子脉冲通过。 However, a successful catheter-based radio-frequency ablation procedure requires the ablation of tissue in the space between the point position adjacent or near the deviation is typically less than 2 mm, in order to prevent the electronic pulses. 在这点上, 精确放置导管电极是一个成功手术的决定性因素。 In this regard, precise placement of the catheter electrode is a decisive factor in the success of the operation.

[0007] 这种现有手术的主要缺点是当心室肌肉搏动时,将导管电极放置在心房内期望消融位置是一个耗时的过程。 The main disadvantage of [0007] Such conventional operation is pulsatile ventricular muscle, the catheter electrodes are placed intraatrial desired ablation locations is a time consuming process. 心房壁或者心肌的运动常常导致导管电极的精确放置非常困难,并且导致导管电极的滑移从而损害不期望消融的心房部分。 Atrial wall or myocardium motion often results in accurate placement of the catheter electrode is very difficult, resulting in slippage of the catheter and the electrode portion to the detriment of the undesired atrial ablation. 因此不能有效的实现基于导管的RF消融的放置,并且延长了手术时间,可以预期,将超过12小时。 Can not be effectively achieved on the RF ablation catheter placement, and prolongs the operation, it is expected more than 12 hours. 此外,在手术中,通常使用X射线或其它照射装置以定位和放置该导管电极,这要求电子生理学者使用沉重的引导保护装置。 Furthermore, in surgery, X-ray irradiation, or other means commonly used in the positioning and placement of the catheter electrode, which requires the use of a heavy electronic physiologist guide protector. 因此,这种不方便性常常因为延长手术时间而放大,进而使得采用基于导管的电极作为组织消融的有效装置逊色不少。 Therefore, such inconvenience is often amplified as prolonged operative time, thus making the use of a catheter-based electrode as an efficient means for tissue ablation lot less.

[0008] 为了克服这些困难,例如,在美国专利号No. 5,741,249中,描述了一个基于导管的微波天线,其中天线包含一远端以将其固定在心房壁上。 [0008] To overcome these difficulties, e.g., in U.S. Pat. No. No. 5,741,249, there is described a catheter-based microwave antenna, wherein the antenna comprises a distal end which is fixed to the atrial wall. 但是,尽管该设计降低了在每次消融过程中天线或者导管电极滑落的可能性,但它没有消除在每个消融步骤中沿期望的消融路径精确的固定天线的耗时任务。 However, although this design reduces the likelihood of each antenna during ablation catheter electrode or sliding down, but it does not eliminate the time-consuming task of ablation at each step along the desired ablation path precise fixed antenna. 因此,如上所述,在每个消融步骤之后,必须重新放置天线,并将天线准确固定在下一个位于消融路径的空间上的或者接近偏差的位置。 Thus, as described above, after each ablation step, the antenna must be repositioned, and an antenna fixed to the lower accurately positioned on a path of the ablation space or near a position deviation.

[0009] 因此,采用导管消融对心房颤动进行有效治疗需要在心房内表面产生长的或者交错的直线或曲线消融损伤。 [0009] Thus, the use of atrial fibrillation catheter ablation treatment requires effective surface of the atrium or interleaving produces a long straight or curved ablation lesion. 之后这些损伤会充当电子脉冲的传导阻隔,从而防止心房颤动。 After conducting these injuries acts as a barrier electrical pulses, thus preventing atrial fibrillation.

[0010] 同样认识到,对于心房颤动的基于导管的有效消融的一个严格要求是在心房腔内固定导管以及微波天线的能力。 [0010] Similarly appreciated, the ability to atrial fibrillation and secure the catheter lumen based on the effective microwave antenna ablation catheter in a strict requirement. 用于心房颤动的最低限度介入的基于导管的医疗手术的发展需要新的导管消融系统,优选的是能够产生长的或者交错的直线或者曲线消融损伤。 Development of a catheter-based medical procedure minimum intervention for atrial fibrillation catheter ablation system needs a new, preferably capable of producing long or staggered straight or curved ablation lesion.

[0011] 美国专利号No. 6,190,382,公布于2001年2月20日,以及美国专利申请号No. 09/459,058,申请日为2001年11月11日,都公开了用于消融患者身体血管内的生物组织的基于射频或者微波能量的导管。 [0011] US Pat. No. No. 6,190,382, published February 20, 2001, and US Patent Application No. No. 09 / 459,058, filed on November 11, 2001, discloses the use of all based on the ablation catheter radiofrequency or microwave energy in biological tissue within the body vessel of a patient. 该导管包括近端,具有末端的远端和从近端延伸到远端的腔。 The catheter includes a proximal end, a distal end and a proximal end to a distal end extending from the cavity. 该导管包括位于导管腔内的延伸的导管引导,其一端固定到导管的远端,另一端接近地延伸到导管腔内以耦合到一个定位装置。 The guide catheter includes a catheter lumen of the extension catheter, which is secured to the distal end of the catheter, and the other end extends close to the catheter lumen to be coupled to a positioning means. 该导管引导可延展到超出导管远端以构成一个环,从而适合于身体血管的内部轮廓。 The catheter may be guided to extend into the interior contour to form a ring, as appropriate for the body vessel beyond the distal end of the catheter.

[0012] 该导管引导携带了具有基于射频或者微波能量天线的导管,该天线位于导管的远端。 [0012] The catheter guide carries a radio frequency or microwave energy based antenna having a catheter, the catheter at the distal end of the antenna. 该天线包括一个螺旋线圈以使导管引导穿过它。 The antenna includes a helical coil to guide the catheter through it. 该射频天线适用于在通常高于300兆赫(MHz)电磁谱频率的微波范围内接收和辐射射频能量,以沿着生物消融路线来消融生物组织。 The RF antenna is adapted to generally above 300 megahertz (MHz) and receiving radio frequency radiation in the microwave range of the electromagnetic spectrum frequency energy to ablate the biological along a route to ablate biological tissues.

[0013] 对于具有上述基于射频或微波能量的导管的更多改进,引入US专利申请号No. 10/306, 757,申请日为2002年11月27日,全文列于此以作参考,其包括与本申请相同的发明人,描述了先进的可偏转并且可塑形的导管结构特点并特别描述了天线部分。 [0013] For further improving the above-described having RF or microwave energy based catheter, incorporated US Patent Application No. No. 10/306, 757, filed November 27, 2002, column entirety herein by reference, which including the same inventor of the present application, describes a deflectable advanced shapeable catheter and structural features described and particularly an antenna portion. 这些特点充分地增强了电子生理学者适应与消融位置轮廓一致的导管和天线的结构和形状的能力,以及准确规定消融路径的能力。 These features substantially enhance the ability of physiologists electronic structure and shape of the contour coincides with the position of the ablation catheter and an antenna adaptation, and the ability to accurately ablate a predetermined path.

发明内容 SUMMARY

[0014] 本发明的导管与美国专利号6,190,382,6, 663,625以及7,004,938,以及申请于2003年8月3日的美国专利申请号10/637,325相比提供了进一步改进和特点。 [0014] The catheter of the present invention and U.S. Patent No. 6,190,382,6, 663,625 and 7,004,938, and application as compared to August 2003, U.S. Patent Application Serial No. 3 10 / 637,325 It provides further improvements and features. 其中,这些改进和特点包括射频(“RF”)发生器以选择性地产生传送到RF天线的可变功率输出的高频RF能量。 Wherein these improvements and features include a radio frequency ( "RF") generator to selectively generate a high frequency RF energy is delivered to the variable output power of the RF antenna. 该RF天线包括螺旋线圈并具有轴向通道以容纳操控控制线。 The RF antenna comprises a helical coil having an axial passage to receive and manipulate a control line.

[0015] 依据本发明的一个实施例,提供了一种改进的基于射频的导管系统,其用于消融身体血管的生物组织,包括患者心房。 [0015] According to an embodiment of the present invention, there is provided an improved radio frequency-based catheter system for ablating biological tissues of a body vessel, comprising a patient heart. 该系统包括微波频率范围内的RF发生器,用于和可插入身体血管的导管进行RF能量传递,并包括位于导管腔内可弯曲的天线引导。 The system includes an RF generator, the microwave frequency range, for insertion into the body vessel and RF energy delivery catheter, and includes an antenna located in the guide catheter lumen bendable. 该导管包括RF传输线以及位于导管远端的RF天线,以为组织消融接收和发送射频能量。 The catheter includes an RF transmission line and the RF antenna of the distal end of the catheter, that receive and transmit RF tissue ablation energy. 将RF天线放置在身体血管之后,启动RF发生器从而为天线提供能量。 After the RF antenna is placed in a body vessel, starting RF generator to provide energy to the antenna. 在一个实施例中,与RF发生器相连的控制器将通过调整用于有效组织消融的微波频率来监视并最小化天线以及天线-组织接口的反射与前向功率比。 Tissue interface reflection ratio of the front power - In one embodiment, an RF generator coupled to the controller to monitor and minimize the antenna, and the antenna by adjusting the effective frequency of the microwave tissue ablation. 在本发明的另一个实施例中,将温度传感系统和RF天线相结合,并通过调整功率设置来监视和控制温度。 In another embodiment of the present invention, the combination of RF antenna and temperature sensing system, and to monitor and control the temperature by adjusting the power setting. 在本发明有代表性的实施例中,可以在预设限度内监视和控制反射与前向功率比和温度,虽然在可替换的实施例中,仅控制这些参数中的一个。 In representative embodiments of the present invention can monitor and control the reflective vs. forward power ratio and temperature within the preset limit, while in alternative embodiments, only one controlling these parameters.

[0016] 通过温度传感器测量的温度改变可能与生物组织的RF能量作用(消融)和天线系统作为一个整体的结合有关。 [0016] RF energy may be related to altered biological tissue (ablation), and the antenna system as a whole about the binding measured by the temperature sensor. 通过建立测量温度的设置点并调整RF频率和在预设温度设置点内向目标组织传送的能量,提供了用于组织消融的有效方法。 By establishing the set point for measuring the temperature and adjust the RF frequency and a predetermined temperature set point energy target tissue within the transmission, it provides an effective method for tissue ablation.

[0017] 在本发明的一个有代表性的实施例中,天线引导包括伸长部分,该伸长部分固定到用于定位、放置以及弯曲控制的控制滑块。 [0017] In an embodiment of the present invention, a representative, the antenna portion includes an elongated guide, which is fixed to the elongated portion for positioning, and placement of the control slide bending control. 在一个实施例中通过使用无线电不透性(radio-opaque)标志物和/或无线电不透性天线元件使得更易于将天线与期望的组织消融路径对齐。 In one embodiment, by using a radio opacity (radio-opaque) marker and / or radio antenna impermeable antenna element makes it easier to align the desired tissue ablation path.

[0018] 将RF天线放置在身体血管内的身体组织附近之后,启动RF发生器从而为天线提供能量。 After [0018] The RF antenna is placed within a body vessel in the vicinity of the body tissue, thereby starting RF generator to provide energy for the antenna. 该RF发生器通过调整用于有效组织消融的微波频率来监视和最小化天线以及天线-组织接口的反射与前向功率比。 Tissue interface reflection ratio of the power of the front - to monitor the RF generator and the antenna, and the antenna is minimized by adjusting the effective frequency of the microwave tissue ablation.

[0019] 在本发明的一个实施例中,设置了传感器来感应来自天线的反射RF能量的量。 [0019] In one embodiment of the present invention, a sensor is provided to sense the amount of the reflected RF energy from the antenna. 如果反射能量过高,则RF发生器将自动调整以按比例缩减合成波形的频率以使组织范围的能量释放最大。 If the reflected energy is too high, the RF generator will automatically adjust to scale down the frequency of the composite waveform to the tissue a maximum range of energy release.

[0020] 在另一个实施例中,导管配置有集成了温度传感系统的RF天线,并通过控制反射功率(反向功率)和检测的温度来优化传送到目标生物组织的RF能量。 [0020] In another embodiment, the catheter is disposed an RF antenna integrated temperature sensing system, and to optimize the delivery of RF energy to the target biological tissue by controlling reflected power (reverse power) and the detected temperature.

[0021] 通过列举本发明特征,并通过下述详细描述和附图,本发明的这些或其他方面的优点将显而易见。 [0021] exemplified by the features of the invention and the following detailed description and the accompanying drawings, these advantages or other aspects of the present invention will be apparent.

附图说明 BRIEF DESCRIPTION

[0022] 通过本发明的一些代表性实施例的详细描述以及结合附图将使得本发明更易理解,附图中相同的附图标记表示相同的部件,其中: Detailed description of the [0022] Some representative embodiments of the present invention by the well such that the present invention be more readily understood in conjunction with the accompanying drawings, the drawings in which like reference numerals represent like parts, wherein:

[0023] 图IA和IB是本发明一个实施例中RF消融导管的代表性侧视图。 [0023] FIGS. IA and IB is a representative side view of the RF ablation catheter embodiment of the present invention.

[0024] 图2A和2B是手柄包含改进操控装置的另一个实施例中RF消融导的代表性侧视图。 [0024] Figures 2A and 2B are improved handle control device further comprising a representative side view of the RF ablation guide embodiment.

[0025] 图3A和;3B是图1或图2中基于射频的导管的远端截面图。 [0025] and FIGS. 3A; 3B is a sectional view of the distal end of the catheter based RF 2 in FIG. 1 or FIG.

[0026] 图4是用于控制依据本发明代表性实施例的图1至3中RF消融导管的RF能量传送的控制系统原理框图。 [0026] FIG. 4 is a control diagram according to a representative embodiment of the present invention is a control system block diagram of an RF ablation catheter delivery of RF energy to 1-3.

[0027] 图5是表示建立和控制使图1至4的系统中反射与前向功率比最小化的微波频率的流程图。 [0027] FIG. 5 is a system diagram 1-4 in the flowchart of the forward power than the minimum frequency of the reflected microwaves to make up and control.

[0028] 图6A和6B是和图3A与类似的截面图,但是描述了依据本发明另一个代表性实施例中改进的RF消融导管,该导管包括一个温度传感器。 [0028] FIGS. 6A and 6B and FIG. 3A is a sectional view similar to, but improved in the described embodiment an RF ablation catheter according to another representative embodiment of the present invention, the catheter includes a temperature sensor.

[0029] 图7是依据本发明代表性实施例的功率和温度控制系统原理框图,其包括图6中RF消融导管。 [0029] FIG. 7 is a schematic block diagram of a power and temperature control system according to a representative embodiment according to the present invention, including RF ablation catheter of FIG. 6.

[0030] 图8是描述图7的系统中控制反射功率和组织温度方法的原理流程图。 [0030] FIG. 8 is a schematic flowchart showing the control system 7 and a reflected power of the method described in FIG tissue temperature.

7具体实施方式 DETAILED DESCRIPTION 7

[0031] 此处公开的实施例提供了用于生物组织消融的基于射频(RF)的导管系统和方法,更具体而言,描述一种控制RF能量以对准生物组织的系统和方法。 [0031] The embodiments herein provide systems and methods for a catheter-based radio-frequency (RF) and, more particularly, describes a method of controlling the RF energy ablation of biological tissue to biological tissue and the alignment system is disclosed. 例如,此处公开的一种方法和系统允许通过控制反射与前向功率的比值来控制RF能量的传送,此处公开的另一种方法和系统除了控制反射/前向功率比之外,还包括用来监视和控制反射温度的温度传感器。 For example, disclosed herein, a method and system allows to control the RF energy by controlling the ratio of reflected and forward power transmission, another method disclosed herein and a control system in addition to the reflection / forward power ratio, but also including for monitoring and controlling the temperature of the temperature sensor is reflected.

[0032] 本领域技术人员在阅读本描述后将会清楚理解,如何通过各种替代性实施例和替代性应用来实现本发明。 [0032] Those skilled in the art will be clearly understood upon reading this description, to implement the present invention and alternative applications by how various alternative embodiments. 不过,虽然此处描述了本发明的多种实施例,但是可以理解此处的这些实施例仅是作为示例,并不是限制。 However, although the herein described various embodiments of the present invention, it will be understood that these embodiments herein are merely by way of example and not limitation. 就这点而论,这些详细描述的各种替代性实施例不应解释为限制在所附的权利要求书中所阐述的本发明的范围和广度。 As such, the detailed description of various alternative embodiments should not be construed as limiting the scope and breadth of the invention in the appended claims set forth herein.

[0033] 本发明的实施例可以用于生物组织的消融。 Example [0033] The present invention may be used to ablate biological tissues. 有利地,这些实施例通过使用作为导管一部分的射频(RF)天线,能够消融位于活的哺乳动物内部血管的组织。 Advantageously, these embodiments by using a radio frequency as part of the conduit (RF) antenna, ablating tissue of a mammal can be positioned inside a blood vessel alive. 该导管能够插入这些哺乳动物的内腔或身体血管中,并且RF天线位于接近要消融的组织,在此处提供RF能量以实现组织消融。 The catheter can be inserted into the body vessel or lumen of a mammal, and to be located near the antenna RF ablated tissue, providing RF energy to achieve tissue ablation here.

[0034] 本发明的实施例还提供一种产生一系列RF能量脉冲,特别是在微波频率范围产生一系列RF能量脉冲的装置,该脉冲经由电气传输线发送到RF天线。 [0034] Example embodiments of the present invention further provides for generating a series of pulses of RF energy, in particular a series of devices generating pulses of RF energy in the microwave frequency range, this pulse is sent to the RF antenna via electrical transmission lines. 该RF能量脉冲的频率可以依据电气传输线的电气特性、以及与组织消融相关的负载阻抗而有选择的变化。 The frequency of the pulses of RF energy ablation may be related to the load impedance according to the electrical characteristics of an electrical transmission line, and a selected tissue changes.

[0035] 在一个实施例中,提供了一种感应与微波频率能量脉冲相关的前向和反射功率的装置,以确定反射与前向功率的比值。 [0035] In one embodiment, there is provided an apparatus forward and reflected power of the microwave frequency associated with an inductive energy pulse to determine a ratio of the reflected and forward power. 然后,可以调整RF发生器的能量脉冲的输出频率以最小化该反射与前向功率比值。 Then, to adjust the output frequency of the RF generator to the reflected energy pulses and the forward power ratio is minimized. 这就将系统能量输出的阻抗精密调整以充分匹配消融负载,并将消融能量传送至所需位置。 This impedance precision adjustment system energy output to match the full load ablation, and ablation energy delivered to the desired location. 这样,不仅提供了将RF能量产生并传送到RF天线以消融组织的装置,还提供了提高RF天线操作效率以减少电气传输线过热的风险的装置。 Thus, not only provides a means to ablate tissue, also provides a device to improve the operating efficiency of the RF antenna to reduce the risk of overheating of the electrical transmission line will generate and transmit RF energy to the RF antenna.

[0036] 在本发明的一个实施例中,如图IA和IB所示,一个射频(“RF”)消融导管100包括适于插入患者的身体血管的可塑形天线装置110,并且该可塑形天线装置110包括将电磁能量传送到治疗点的射频天线。 [0036] The embodiment, shown in FIG. IA and IB In one embodiment of the present invention, a radio frequency ( "RF") ablation catheter 100 adapted for insertion into a body vessel comprising a shapeable antenna apparatus 110 of the patient and the shapeable antenna apparatus 110 includes a transmitting antenna to a radio frequency electromagnetic energy treatment point. 在描述本发明的可塑形天线装置110之前,先描述该导管100。 Before describing the present invention shapeable antenna apparatus 110, the conduit 100 is described first.

[0037] 该导管100具有包括近端部分130和远端部分140的柔性延伸的管状体120。 [0037] The catheter 100 includes a proximal portion 130 having a flexible extension of the tubular body and the distal end portion 140 120. 一个或多个内腔(intracavity lumens) 150(图3A,3B)从该导管100的近端部分130延伸到远端部分140。 One or more lumens (intracavity lumens) 150 (FIGS. 3A, 3B) extending from the proximal portion 130 of the catheter 100 to the distal end portion 140. 手柄盘160位于导管100的近端部分130以提供必要的操控和定位控制,其将在下文详细介绍。 Disc 160 at the proximal end of the handle portion 130 of the catheter 100 to provide the necessary handling and positioning control, which will be described in detail below. 导管100的近端160具有耦合部件170以将该导管100连接到一个或多个电子装置,例如图4描述的用于支持消融过程的RF发生器和控制系统。 Having a proximal end 160 of catheter 100 to the catheter 170 the coupling member 100 connected to one or more electronic devices, for example, to support the ablation process described in FIG. 4 and the RF generator control system.

[0038] 该导管100的尺寸根据适用于特定医用过程的需要而调整,这是在医学界众所周知的。 [0038] The size of the catheter 100 is adjusted according to the medical procedure for a particular need, which is well known in the medical profession. 在一个实施例中,该导管100用于消融心肌组织;但是,在可替换的实施例中,该导管100可以用于消融其它类型的组织。 In one embodiment, the catheter 100 for ablating myocardial tissue; however, in an alternative embodiment, the ablation catheter 100 may be used in other types of tissue. 通常,该导管的管状体120可以通过一种在身体血管环境中生物相容的聚合物材料来构建。 Typically, the catheter tubular body 120 may be constructed by means of a body vessel in a biocompatible polymeric material in the environment. 并不是进行限制,这些材料的例子包括具有不同程度的辐射不透性、硬度和弹性的,来自Autochem Cermany的pebax®,聚乙烯,聚亚安酯,聚酯,聚酰亚胺和聚酰胺。 Is not to be limiting, examples of such materials include those having different degrees of radiopacity, hardness and elasticity, the Pebax® from Autochem Cermany, polyethylene, polyurethane, polyester, polyimide, and polyamide.

[0039] 该导管100可以由使用一个或多个前文提到的材料的多个节组成,以使得该导管体120在朝向它的远端时逐渐变得柔性。 [0039] The conduit 100 may be formed using one or more of the previously mentioned materials plurality of sections composition, so that the catheter body 120 at its distal end toward gradually becomes flexible. 这些节通过热粘合,对接,或胶接连接在一起。 These sections by thermal bonding, butt, or glued together. 编织加强层也可以增加到管状体120的圆周表面以实现该导管100所需的硬度和抗扭强度级别。 Braided reinforcing layer may also be added to the circumferential surface of the tubular body 120 to achieve the desired stiffness of the catheter 100 and torsional strength level. 这就允许导管100经由患者的身体血管前进和通过,并且使扭矩沿着导管的长度从近端部分传递到远端部分。 This allows the catheter body 100 and proceeds through the patient's vessels via, and the torque transfer along the length of the catheter from the proximal portion to the distal portion.

[0040] 此外,参考图3A和:3B,将更详细描述管状体120的远端部分140。 [0040] Further, and with reference to FIGS. 3A: 3B, the distal end of the tubular body 120 will be part 140 is described in detail. 该部分可以包括比近端部分130更软的聚合物,具有少量或没有编织层,从而提供期望的柔性以适应可塑形天线装置110的远端弯曲(deflection)和成形。 The portion may comprise softer than the proximal portion 130 of the polymer layer with little or no braiding, to provide the desired flexibility to accommodate distal end of the antenna device 110 may be shaped bending (deflection) and forming. 通过使用预先成形的弯曲元件180 和/或弯曲调节元件190可以实现可塑形天线装置110的弯曲和成形。 By using the preformed curved element 180 and / or bending of the bending regulating member 190 can be realized and shaped shapeable antenna apparatus 110. 该预先成形的弯曲元件180和/或弯曲调节元件190可以经由管状体从手柄盘160延伸到管状体140的远端部分140。 The preformed curved element 180 and / or bending regulating member 190 may extend from the handle plate via the tubular body 160 to the distal end 140 of the tubular body portion 140. 该管状体的远端部分140包括RF天线250,该天线具有用于身体血管消融的柔性的、螺旋盘绕辐射天线元件255。 Distal end of the tubular body portion 140 includes an RF antenna 250, the antenna having a flexible body vessel ablation, the radiating antenna element 255 spiral wound.

[0041] 在代表性的实施例中,RF天线250包括螺旋式缠绕的导电材料或者剥线从而形成柔性的,螺旋线圈绕组。 [0041] In a representative embodiment, the RF antenna 250 includes a conductive material or stripping of a spirally wound to form a flexible, helical coil winding. 适当线圈绕组的直径、斜度和长度,以及导电材料或剥线的选择可以根据特定过程和灵活性需要而不同。 The diameter and the coil winding, and the length of the slope, and selecting the stripped conductive material or may be different depending on the particular procedure and flexibility requirements. 在描述的实施例中,RF天线连接到一个或多个导体沈0,该导体沿导管的长度延伸并且经由耦合件170连接到图4的功率控制系统。 In the embodiment described, the RF antenna is connected to one or more conductors sink 0, the conductor extending along the length of the conduit and connected to the power control system of Figure 4 via the coupling member 170. 虽然在描述的实施例中导体260是柔性网格或编线结构,但是可以理解这些导体可以在其他实施例中有替代结构,例如薄膜导电材料,或者延伸的、共轴的,圆周对齐的内部或外部导体等等。 Although in the embodiment described embodiments of conductor 260 is a flexible mesh or braided wire structure, it will be appreciated that these conductors may have alternative configurations in other embodiments, a conductive material such as a film, or extending, coaxial, circumferentially aligned inner the outer conductor or the like.

[0042] 图1,2,3A和;3B中的可塑形导管装置可以携带一个或多个心电图(ECG)电极(未示出)以允许医生在组织消融之前和之后获得最优的组织接近和导电活性。 [0042] and FIG 1,2,3A; 3B posable the conduit means may carry one or more electrocardiogram (ECG) electrodes (not shown) to allow the physician before and after tissue ablation for optimal tissue proximity and conductive active. 这些电极可以沿着导管的长度固定在适当的位置。 The electrodes may be fixed in position along the length of the conduit.

[0043] 预塑形弯曲元件180和/或弯曲调节元件190可以接近地固定到弯曲控制装置220(图2A,2B)或者滑块200(图1A,1B)。 [0043] preforms the bending elements 180 and / or bending regulating member 190 can be secured to the bending close to the control device 220 (FIGS. 2A, 2B) or the slider 200 (FIGS. 1A, 1B). 在一个实施例中,滑块200可滑动地嵌入手柄盘160的轴向槽。 In one embodiment, slider 200 slidably fitted into the axial groove 160 of the handle plate. 滑块200沿着轴向槽的轴向运动使得医生将可塑形天线装置110在直线结构(图1A)、弯曲的塑形结构(图1B)之间,或者任何结构之间塑形或弯曲。 The axial movement of the slider 200 along the axial slot so that the physician shapeable antenna apparatus 110 in a straight configuration (FIG. 1A), the bending between the shaping structure (FIG. 1B), or between any bending or shaping structure. 滑块200可以包括摩擦获取装置(未示出)以在轴向槽中保持紧固的位置。 Acquiring slider 200 may include a friction device (not shown) to maintain the axial groove in the fastening position. 很多这样的装置可以通过商业渠道获得。 Many of these devices can be obtained through commercial channels. 这样装置例如包括设定释放装置,压力开关或者自锁装置。 Such apparatus includes, for example setting release means, pressure switch or self-locking device.

[0044] 图2A和2B描述了和上述RF消融导管100类似的RF消融导管210,但是其包括弯曲控制装置220的可选实施例,以塑形或弯曲可塑形天线装置110。 [0044] Figures 2A and 2B and described above RF ablation catheter 100 similar to the RF ablation catheter 210, which includes an optional but bend control device 220 embodiments, bending or shaping to shapeable antenna apparatus 110. 该弯曲控制装置220 可以包括可旋转环230,其圆周地围绕并可旋转地耦合到手柄盘160的手柄杆M0,以控制预塑形弯曲元件180和/或弯曲调节元件190的轴向运动。 The bending control device 220 may include a rotatable ring 230, which is circumferentially and rotatably coupled to the handle disk M0 160 around the handlebar to control the pre-shaping member 180 is bent and / or axial movement of the adjusting member 190 is bent. 该手柄盘160可以容纳转换装置以将卡圈230的旋转运动转换为预塑形弯曲元件180和/或弯曲调节元件190的轴向运动。 The handle 160 may accommodate disk rotational motion converting means 230 converts the collar member 180 is bent and / or curved axial movement regulating member 190 is pre-shaped. 和手柄杆240相比,环230的旋转运动使得医生将可塑形天线装置110在直线结构(图2A)、弯曲的塑形结构(图2B)之间,或者任何结构之间塑形或弯曲。 And a handle bar 240 as compared to the rotational movement of ring 230 so that the physician will be shaped antenna apparatus 110 in a rectilinear configuration (FIG. 2A), between the curved shaped configuration (FIG. 2B), or between any shaped or bent structure.

[0045] 图4是控制系统300的原理框图,该控制系统300控制依据本发明实施例的图1至3中消融导管的RF输出信号。 [0045] FIG. 4 is a block diagram of a control system 300, the control system 300 controls the output signal of the RF ablation catheter in accordance with an embodiment of the present invention to 13. 图4描述了该系统的电气和信号成分。 And FIG. 4 describes the electrical signal components of the system. 导管系统300包括电源开关308,供电系统310,微控系统320,RF信号发生器或振荡器330,包括前置放大器331 的RF放大器334,RF双向耦合器336,控制输入350,显示装置360,以及报警输出370。 The catheter system 300 includes a power switch 308, the power supply system 310, a micro control system 320., RF signal generator or oscillator 330, comprising an RF amplifier 331 of the preamplifier 334, RF bi-directional coupler 336, a control input 350, a display device 360, and an alarm output 370. 该双向耦合器336连接到RF传输线342的远端,并且传输线的近端连接到RF天线343。 The bidirectional coupler 336 is connected to the distal end of the RF transmission line 342, and the proximal end of the transmission line 343 is connected to the RF antenna. 该传输线342和天线343设置在可操控消融导管430上。 The transmission line 342 and the antenna 343 provided on the steerable ablation catheter 430. 在一个实施例中,消融导管340可以等同于图1到3中的消融导管100,并且天线343可以是图3A和中的螺旋RF天线250, 同时传输线342包括导体沈0。 In one embodiment, the ablation catheter 340 may be equivalent to 1 to FIG. 3, the ablation catheter 100, and antenna 343 may be helical in FIG. 3A and the RF antenna 250, while the transmission line 342 includes a conductor Shen 0.

[0046] 基于RF的导管系统300通过普通的交流电源供电,并且其也可以采用适当的直流电源供电。 [0046] RF catheter system 300 through a common AC power supply, and it may also be appropriate DC power supply based on 电源开关300将电源和供电系统310连接起来。 The power switch 300 connects the power supply 310 and power supply systems. 该供电系统提供主要的患者安全隔离和为执行有效组织消融的装置所需的各种直流电压。 The main power supply system to provide patient safety and isolation various DC voltages necessary for the implementation of an effective tissue ablation means.

[0047] 基于微处理器的微控制器320,提供用户输入,输入和输出的显示,并设置系统报警条件。 [0047] The microprocessor-based microcontroller 320, provides a user input, displaying the input and output of the system and set an alarm condition. 微控制器320也监视和控制RF功率合成并且与RF天线343和消融组织通信。 The microcontroller 320 can also monitor and control the RF power combiner and in communication with antenna 343 and RF ablation of tissue. 如图4所示,该微控制器320监视和控制RF信号振荡器330,该振荡器接收来自供电系统310 的电源。 As shown, the microcontroller 320 monitors and controls the RF signal oscillator 330, the oscillator 310 receives power from the power supply system 4. RF信号振荡器在由微控制器320决定和控制的功率级别和频率上产生连续的RF 频率波信号332。 RF signal oscillator generates a continuous wave RF frequency signal 332 at the frequency and power level determined by the microcontroller 320 and controls.

[0048] 在本发明的实施例中,RF信号振荡器330电耦合到功率放大器334。 [0048] In an embodiment of the present invention, RF signal oscillator 330 is electrically coupled to the power amplifier 334. 功率放大器334包括前置放大器331,该前置放大器331初始地放大来自RF发生器的信号波332,并产生第一序列的相对低能量脉冲。 The power amplifier 334 includes a preamplifier 331, the preamplifier 331 initially amplified signal from the RF wave generator 332, and generates a relatively low energy pulse of the first sequence. 在经RF放大器334放大之后,该能量脉冲经由传输线342 传送到位于将被消融的组织附近的RF天线343。 After amplified by the RF amplifier 334, the pulse energy is transmitted via a transmission line 342 positioned adjacent tissue to be ablated RF antenna 343.

[0049] 如图4所示,双向耦合器336电插入在放大器334和传输线342之间。 [0049] As shown in FIG 4, the bidirectional coupler 336 is electrically interposed between the amplifier 334 and the transmission line 342. 该耦合器沿着传输线采样相对低能量前向脉冲以及由目标消融组织反射的能量脉冲,并使用采样信号作为到微控制器320的反馈。 The coupler samples the relatively low energy pulse prior to the pulse and the energy reflected by the target tissue ablated along the transmission line, and using the sampled signal as a feedback to the microcontroller 320. 在耦合器336处采样信号所提供的反馈机制对于按比例缩小反射能量的量是有用的。 Feedback mechanism in the coupler 336 provides the sampled signal to the scaled-down amount of the reflected energy are useful. 太多的信号反射可能潜在破坏敏感的系统300的元件或引起患者受伤。 Too many elements reflected signals that could potentially damage sensitive system 300 or cause patient injury.

[0050] 通过和双向耦合器336电力通信,微控制器320监视前向和反射能量脉冲。 [0050] forward and reflected energy pulses and the front power communication bidirectional coupler 336, the microcontroller 320 monitors. 然后微控制器320确定反射与前向能量脉冲的比值。 The microcontroller 320 then determines the ratio of the forward and reflected energy pulse. 在一个实施例中,该比值包括电压驻波比(VSffR),如下计算: In one embodiment, the ratio comprises a voltage standing wave ratio (VSffR), calculated as follows:

[0051] [0051]

Figure CN101484083BD00101

[0052] 其中Γ ^代表了沿RF传输线342使用适当边界条件计算的负载反射系数。 [0052] where Γ ^ represents the load reflection coefficient is calculated using the appropriate boundary conditions along the RF transmission line 342.

[0053] 低的比值将指示系统产生的多数能量用于消融负载,代表装置和消融负载之间获得了匹配的阻抗。 [0053] Most low ratio indicating system generates energy for obtaining impedance matching between the load ablation, ablation of the representative device and the load. 另一方面,高的比值将指示系统产生的可观数量的能量被反射,表示由于较差的阻抗匹配所导致的高回波损失或泄露。 On the other hand, a high ratio indicating considerable amount of reflected energy is generated by the system, indicates a high impedance due to poor return loss caused or leakage.

[0054] 对于RF传输线342的阻抗受脉冲332频率的影响,一个实施例提供了一种装置, 其能够使系统功率输出的频率改变,从而使得线路阻抗和负载阻抗匹配。 [0054] the impedance of the RF transmission line 342 is affected by the pulse frequency of 332, one embodiment provides an apparatus which enables the system to change the frequency of the power output, so that the line impedance and the load impedance. 用于感应的装置(例如,在一个实施例中是双向耦合器)和用于调整的装置包括调整RF信号源330的装置和响应控制装置(例如,微控制器320)的RF放大器334,从而使传输线阻抗与负载阻抗匹配。 Means for sensing (e.g., in one embodiment, is a bi-directional coupler), and means for adjusting includes adjusting the RF signal source means and responsive to the control means (e.g., microcontroller 320) 330 RF amplifier 334, thereby that the transmission line impedance and the load impedance. 例如,如果比值指示太多的能量被反射(例如,高的VSWR),该微控制器320调整由振荡器330产生的RF信号332的频率从而实现降低反射和前向能量脉冲的比值。 For example, if the ratio indicates too much energy is reflected (e.g., the VSWR is high), the microcontroller 320 adjusts the frequency of RF signal 330 generated by the oscillator 332 and thus achieve a reduction in the reflection ratio of the forward energy pulses. 该功率比值的降低实现了在传输线和消融负载之间的阻抗匹配。 Reducing the power ratio between the impedance matching of the transmission line and the load of the ablation. 可接受的回波损失量依赖于实际情况。 Acceptable return loss depends on the actual situation. 但是由于不可能达到完全理想的阻抗匹配,微控制器320可以允许用户调整频率以使得该比值降低到某些阈值之下。 However, since it is impossible to achieve the desired impedance matching complete, the microcontroller 320 may allow the user to adjust the frequency such that the ratio drops below a certain threshold. 该阈值可以低于1.4:1,在一个实施例中该阈值为0.4:1。 The threshold may be less than 1.4: 1, in one embodiment, the threshold is 0.4: 1.

[0055] 因为负载阻抗可能在组织类型之间大范围的变化,并且可以依据组织周围的流体(例如充血的腔或者室)的质量和数量而变化,控制装置支持宽范围的频率调整设置以在本领域中灵活配置系统300。 [0055] Since the load impedance may vary between a wide range of tissue types, and may vary depending on the fluid (e.g. congestive heart cavity or chamber) the quality and quantity of surrounding tissue, to support a wide range of frequency adjustment means arranged to control the this art flexible configuration system 300.

[0056] 获得阻抗匹配后,微控制器320调整功率放大器334来产生一系列相对高能量脉冲,其将经由传输线传送到RF天线以实现组织消融。 After [0056] The impedance matching is obtained, the microcontroller 320 to adjust the power amplifier 334 to produce a series of relatively high energy pulse, which is transmitted via the transmission line to the RF antenna to achieve tissue ablation. 在本发明的一个实施例中,用于消融过程所产生的功率级别大约为60瓦特。 In one embodiment of the present invention, for an ablation power level produced by the process is about 60 watts.

[0057] 除了通过RF脉冲频率来提供监视和调整功能之外,微控制器320还与用户(例如与电子生理学者)交流多种信号和指示。 [0057] In addition to providing monitoring and adjustment by the pulse frequency than RF, the microcontroller 320 further (e.g. with an electronic physiologist) alternating with a variety of signals indicating user. 该系统在RF频率、输出功率、以及设置消融持续时间上支持手动优先(marumloverride)。 The ablation system supports manual priority (marumloverride) over the duration of the RF frequency, output power, and setting. 在典型结构中,本发明的控制输入350可以装配有多线显示器,调整输出功率级别和消融周期的一组上下键,激活消融过程的消融开/关键, 改变显示模式和/或配置I/O端口的模式/设置键。 In a typical configuration, the present invention is the control input 350 may be equipped with a multi-line display, a set of upper and lower adjustment button output power levels and ablation cycle, the ablation on / off key to activate the ablation process, change the display mode and / or configuration of the I / O mode of the port / set.

[0058] 在消融过程中持续监视RF放大器334的输出功率级别。 [0058] continuously monitoring the output power level of the RF amplifier 334 during ablation. RF双向耦合器336提供在衰减级别上采样前向和反向功率级别的功能,其连接到微控制器组件。 RF bidirectional coupler 336 is provided on the level of attenuation before sampling and reverse power level function, which is connected to the microcontroller component. 该微控制器组件比较这两个信号并调整两个信号源和前置放大器/功率放大器增益从而达到最低的反向与前向功率比。 The microcontroller compares the two components of two signals and adjusts the signal source and pre-amplifier / power amplifier gain so as to achieve the lowest forward ratio and the reverse power.

[0059] 基于RF的导管系统300在900MHz到930MHz的典型范围内监视和控制微波频率和功率输出以最小化反射与前向功率比。 [0059] RF-based catheter system 300 monitors and controls the microwave frequency and power output in the range of 900MHz to 930MHz is typical to minimize the reflected power than the previous. 该RF天线343典型的是已制作好的,并且在与将消融的生物组织和充满流体的动物身体血管接近的生理盐水中调谐为915MHz的天线。 The RF antenna 343 is typically ready-made, and an antenna tuned to 915MHz with biological tissue ablation and fluid-filled animal body vessel close to physiological saline. 当进入身体血管并将要接触生物组织以消融时,该RF天线343的电尺寸可以稍微临时改变以增加反射功率。 When the blood vessel and into the body to be contacted to ablate the biological tissue, the size of the electrical RF antenna 343 may be slightly altered to a temporary increase in the reflected power. 增加的反射功率降低了用于辐射的总功率,并因此降低了有效的组织消融。 Reflected power increases the power for reducing the total radiation, and thus reduces the effective tissue ablation. 如果该反射功率是不受约束的并且增长过大,RF天线343将发生局部加热并导致不希望的消融影响。 If the reflected power is unconstrained and grow too large, RF antenna 343 results in local heating and ablation of undesirable impact.

[0060] 图5是依据本发明实施例的用于生物组织消融的方法流程图。 [0060] FIG. 5 is a flowchart illustrating a method for ablation of biological tissue embodiment of the present invention. 该方法可用于编程微控制器320的指令集以执行此处描述的消融过程。 This method can be used to program instruction set of the microcontroller 320 to perform the ablation procedure described herein.

[0061] 该过程在用户为系统提供电源供应之后开始,通常通过接通电源开关301开始。 [0061] The process after the user starts to provide power supply for the system, typically by turning the power switch 301 begins. 在步骤401,该系统通常运行一系列初始化程序以建立系统完整性。 In step 401, the system typically runs a series of initialization procedures to establish the integrity of the system. 自检可包括,例如,在显示装置显示一个标志并为适当的硬件检查系统ROM。 Self-test can include, for example, a display and a flag for the appropriate hardware in the display device inspection system ROM.

[0062] 在条件框403,如果上电自检失败,则过程分支到系统错误。 [0062] In the condition block 403, if the power-on self-test fails, then the process branches to a system error. 在一个实施例中,如果上电自检失败,则报警输出370将响起。 In one embodiment, if the power-on self-test fails, the output 370 will sound the alarm.

[0063] 如果在条件框403中通过自检,则在步骤405中自动设定或者由电子生理学者手动设定消融参数。 [0063] If the condition in block 403 by the self-test is automatically set in step 405 or manually set by the electronic physiological ablation parameters. 在一个实施例中,该消融参数是消融功率和消融时段。 In one embodiment, the ablation power ablation parameters and the ablation period. 预先设定的消融参数可以在步骤407和408中改变。 Preset ablation parameters may be changed in steps 407 and 408. 一旦设定了消融参数,操作者可以选择是否开始消融过程(步骤406)。 Once the ablation parameters are set, the operator may select whether to start the ablation process (step 406). 在初始化消融过程中,在持续监视条件下执行消融(步骤409),以便可以对振荡器330的频率做适当的调整,就像测量反射与前向功率过高的情况一样。 In the initialization process of ablation, the ablation is performed under conditions of continuous monitoring (step 409), so that it can make the appropriate adjustments to the frequency of the oscillator 330, as to measure the reflected power is too high as the previous case. 可以在实时监视几个参数以确保没有超过临界系统阈值。 Several parameters can be monitored in real time to ensure that the system does not exceed the critical threshold. 例如,在步骤409中,可以监视功率输出及反射/前向功率比,以确保提供规定的消融照射量。 For example, in step 409, the power output may be monitored and the ratio of the reflected power / forward, to ensure a predetermined irradiation amount of ablation. 太多的照射将导致不希望的结果,例如消融了良性的组织。 Too much illumination will lead to undesirable results, such as ablation of benign tissue.

[0064] 如果检测到反射/前向功率比高于预先设定的限度(步骤410),则关闭RF放大器并且在图4中报警输出370处的系统报警将响起(步骤411),并停止消融过程(412)。 [0064] limit (step 410) if it is detected before the reflection / power ratio is higher than the previously set alarm is turned off and the output of the RF amplifier at the alarm system 370 in FIG. 4 will sound (Step 411), the ablation is stopped and process (412). 如果比值低于预先设置的限度,但是功率输出高于预先设置的限度(步骤413),则RF放大器将再次关闭并且报警响起(步骤412)。 If the ratio is below the preset limit, the power output is higher than the limit (step 413) set in advance, the RF amplifier is closed again and the alarm sounded (step 412). 但是,只要功率比值和功率输出在预先设定的限度内,则消融过程将继续直到到达消融截止时间(步骤414),之后系统会返回步骤405并等待输入随后消融过程的消融参数。 However, as long as the power ratio and the power output within the limits set in advance, then the process will continue until the ablation ablation deadline (step 414), then the system returns to step 405 and waits for input parameters of the ablation procedure subsequent ablation. 用户将设置消融时段作为进入步骤405的一个参数。 The user set time period as a parameter in the ablation proceeds to step 405. 可以提供任何合适的报警输出,包括语音、视图、或两者都提供。 It may be any suitable alarm output, including voice, view, or both.

[0065] 图6A和6B描述了依据本发明另一个实施例的消融导管500的近端。 [0065] FIGS. 6A and 6B depict a proximal ablation catheter according to another embodiment of the present invention 500. 该消融导管500和图1到3中的导管100类似,但进一步包括温度传感器510。 The ablation catheter 500 is similar to FIGS. 1 to 3 and the catheter 100, but further includes a temperature sensor 510. 导管500其它方面与图1至3中导管100相同,并且相同的附图标记表示相同元件。 Conduit 500 to the same as the other aspects of the catheter 100 in FIG. 13, and like reference numerals denote like elements. 温度传感器510可以是热敏电阻,热敏电偶等等。 Temperature sensor 510 may be a thermistor, thermal galvanic like. 温度传感器510在导管500的远端附近具有传感末端或者热敏电偶接头520,并具有经由导管腔270从接头520延伸到导管近端的一对导体530、532,在导管近端它们被连接到下文将参考图7和8详细描述的控制电路。 A temperature sensor 510 near the distal end of the catheter 500 has a sensing end or thermal galvanic connector 520, having a pair of conductors 530, 532 and catheter lumen 270 extending from the proximal end of the catheter to the connector 520 via the catheter at the proximal end thereof It is connected to the control circuit 78 hereinafter described in detail and with reference to FIG. 虽然在图6A和6B的实施例中温度传感器510被安装在导管的内部,但是可以理解在可选的实施例中,其可以沿导管的外侧固定,或者安装在导管的壁上。 Although the temperature sensor 510 is installed inside the conduit 6A and 6B in the embodiment, it will be appreciated that in alternative embodiments, it may be fixed along the outside of the catheter or mounted on a wall of the catheter.

[0066] 图7和8描述了控制系统600和相关的方法,用于监视和控制包括温度传感器的RF消融导管(类似于图6A和6B中的导管500)中的反射/前向功率比、功率输出以及温度。 [0066] FIGS. 7 and 8 describe the control system 600 and associated method, for monitoring and controlling the temperature sensor comprises a reflected RF ablation catheter (similar to the catheter 500 in FIGS. 6A and 6B) is / forward power ratio, power output and temperature. 系统600包括电源开关602,以及可以与图3中的供电系统310相同的供电系统604, 供电系统604用于为图7所示的系统的各元件供电。 Each component system 600 includes a power supply system power switch 602, and 604 can, with the power supply system 604 for the power supply system of FIG. 3 have the same power system 310 shown in FIG. 7. 系统600包括微控制器610,其依据编程指令和操作者在控制输入612的输入来控制系统的操作。 The system 600 includes a microcontroller 610, which according to programmed instructions and operator control input 612 to control the operation of the system. 显示模块614和输出报警模块615连接到微控制器610的适当的输出。 The display module 614 and an output connected to the alarm module 615 to the appropriate output of the microcontroller 610.

[0067] 微控制器610也连接到RF信号发生器或振荡器616,该振荡器可以是锁相环(PLL)振荡器。 [0067] The microcontroller 610 is also connected to the RF signal generator or oscillator 616, the oscillator may be a phase locked loop (PLL) oscillator. RF信号振荡器616连接到功率放大器618,功率放大器618包括首先放大来自RF振荡器616的输出信号的前置放大器,以及最后放大信号的第二RF放大器。 RF signal oscillator 616 is connected to a power amplifier 618, power amplifier 618 includes a preamplifier is first amplified RF output signal from the oscillator 616, a second RF amplifier and a final amplified signal. 在由RF放大器618放大之后,脉冲RF信号经由双向耦合器620传送到消融装置500的RF传输线560。 After amplified by the RF amplifier 618, a pulsed RF signal is transmitted via the bidirectional coupler 620 to the RF transmission line 560 of ablation device 500. 类似于前述实施例(图4)的控制电路,该双向耦合器620采样沿着传输线传送到RF天线550的相对低能量前向脉冲,并采样从目标消融组织反射回的能量脉冲,并将前向和反射脉冲采样提供到微控制器610作为反馈。 (FIG. 4) a control circuit similar to the foregoing embodiments, the bidirectional coupler 620 samples transmitted along the transmission line to the RF antenna to the front relatively low energy pulse 550, and the sampling pulse energy is reflected back from the target tissue is ablated, and the former and sampling the reflected pulses supplied to the microcontroller 610 as the feedback. 温度信号检测和条件模块622在RF传输线560的端部连接到温度信号导体530,532 (参见图6A,6B),并且模块622也连接到微控制器610。 Signal detection and temperature conditions module 622 at the end of the RF transmission line 560 is connected to the temperature signal conductor 530, 532 (see FIGS. 6A, 6B), and the module 622 is also connected to the microcontroller 610.

[0068] 如前述实施例,微控制器被编程以监视功率输出和前向以及反射能量脉冲,并计算前向与反射能量脉冲之间的比值,或者与上文图4和5的实施例中控制系统有关的、前述定义的电压驻波比VSWR。 [0068] As the aforementioned embodiment, the microcontroller is programmed to monitor the output power and the forward and reflected energy pulses, and the ratio between the reflected energy and calculating the pulse front, above or the embodiment of Fig 4 and 5 For the control system, the definition of the voltage standing wave ratio VSWR. 此外,在本实施例中,该微控制器也被编程以监视由温度传感器520检测的温度,该温度和由消融过程所产生的组织温度非常接近,因为该温度传感器520 接近消融点。 Further, in the present embodiment, the microcontroller is also programmed to monitor the temperature detected by the temperature sensor 520, tissue temperature and the temperature generated by the ablation procedure is very close, because the temperature sensor 520 near the ablation points. 很容易理解在可选的实施例中,温度传感器520可以设置在导管的外表面或者导管的末端。 Readily appreciated that in an alternative embodiment, the temperature sensor 520 may be provided at the end of the outer surface of the conduit or conduits.

[0069] 在图7和8的实施例中,如前述实施例,微控制器610被编程以调整频率从而达到最小的反射与前向功率比,并调整RF功率级别以达到选定的温度设置。 Temperature Setting [0069] In the embodiment of FIGS. 7 and 8, the preceding embodiments, the microcontroller 610 is programmed to adjust the frequency to achieve minimum reflected power ratio of the forward, and adjust the RF power level to achieve the selected . 该温度设置可以是温度设置点加上或减去几个度数,或者可以是选定的温度范围,如图8的流程图相关的详细描述。 The setting temperature may be a temperature set point plus or minus a few degrees, or may be a selected temperature range, the detailed description related to the flowchart shown in FIG. 8. 该反射功率与生物组织和天线系统共同的联合阻抗成比例,并因此最小化反射功率与系统阻抗匹配相同,将传送到将消融组织的前向功率的传输最大化。 The biological tissue and the reflected power the antenna system impedance is proportional to the common joint, and thus minimize the reflected power system impedance and the same, be transferred to maximize the forward power transmission of the ablated tissue. 同时,温度传感器所测量的温度改变可以与生物组织的RF能量作用(消融)及天线系统的结合相关。 Meanwhile, the temperature change measured by the temperature sensor may be RF energy effect on tissue (ablation) in conjunction with the antenna system and relevant. 通过建立测量温度的温度设置点,并调整传送到在预设温度设置点中的目标组织的RF频率和功率,可以提供有效的组织消融方法。 By establishing a temperature set point measurement of the temperature, and adjusted to an RF frequency and transmit power of the target tissue at a predetermined temperature set points, can provide effective tissue ablation. 虽然本实施例使用检测温度和反向与前向功率比作为调整RF信号参数中的控制参数以达到接近用户或缺省设置的温度和功率比,但是可选的实施例可以单独使用温度作为控制参数。 Although the present embodiment as a control using the detected temperature and the previous reverse power control parameter adjustment of the RF signal parameter as a ratio to reach a temperature close to the power ratio and the user or the default setting, but alternative embodiments may be used singly temperature parameter. 微控制器也可以监视输出功率和温度以确保它们都不超过安全操作的最大限度。 The microcontroller may monitor the output power and temperature to ensure that they do not exceed the maximum safe operation.

[0070] 在图7和8的系统中,微控制器通过控制振荡器330调整RF频率,因此也调整反射/前向功率比。 [0070] In the system of FIGS. 7 and 8, the microcontroller 330 to adjust the oscillator by controlling the RF frequency, and therefore to adjust the ratio of the reflection power / forward. 传送的RF功率可以通过控制放大器618调整大小,从而调整反射温度。 RF power may be transmitted by the control amplifier 618 to adjust the size to adjust the temperature of the reflector. 图8 的流程图描述了依据本发明实施例的消融过程的步骤,其使用了图7的控制系统以及如图6所示包含温度传感器的RF消融导管。 FIG 8 is a flowchart of the steps of the ablation procedure described embodiment of the present invention is based, using a control system of Figure 7 comprises a temperature sensor and an RF of the ablation catheter shown in Figure 6. 首先由开关602开启电源(步骤650),然后执行上电重置,初始化,以及自检过程(步骤65幻。与上述图5中步骤401相关的描述相同,在该步骤中,系统运行一系列初始化程序以建立系统完整性。如果自检失败(条件框660),将关闭RF放大器并且消融过程将停止(步骤665),并且将显示并响起报警(步骤670)。如果自检成功,缺省或者预先用户选择的参数将显示在显示模块614上,在消融过程开始之前, 系统将等待用户开启消融开关(步骤680)。 First switch 602 is turned on by the power supply (step 650), then perform the power-on reset, initialization and self-test (step 65 phantom. In the same step 401 in FIG. 5 related description, in this step, the system is running a series of initialization procedure to establish the integrity of the system. If the test fails (conditional block 660), turn off the RF amplifier and the ablation process is stopped (step 665), and the display and sounds an alarm (step 670). If the test is successful, the default or previously user-selected parameters are displayed on the display module 614, prior to the ablation process begins, the system waits for the user to turn the ablation switch (step 680).

[0071] 可以在消融过程开始时由操作者在输入模块612调整或设置消融参数(步骤685)。 [0071] The ablation parameters may be at the ablation procedure begins by the operator to adjust or set the input module 612 (step 685). 可以由操作者改变的参数可以是温度设置点,功率级别,频率,以及消融时段。 Can be changed by the operator parameter may be the temperature set point, power level, frequency, and ablation time. 期望的参数将依据目标生物组织和其它因素而变化。 Desired parameters will vary according to the target tissue and other biological factors. 该系统包括频率和功率级别的缺省初始值, 并且两者都可以必要地调整以达到可能的最低反向/前向功率比,和过程或接近温度设置点的传感器520所检测的温度。 The system includes a default initial values ​​of the frequency and power level, and both can be adjusted to achieve the necessary lowest possible reverse / forward power ratio, and a process temperature sensor disposed at or near point 520 detected. 除了预先设定或操作者选定的操作功率级别、温度级别、频率以及消融时段之外,该系统也具有独立于控制环的为安全操作所设定的功率比、功率和温度的固定的最大限度。 In addition to the pre-set selected by the operator or the operating power level, temperature level, ablation time and frequency, the system also has a power ratio independent of the control, power and temperature for the safe operation of the set ring fixed maximum limit. 最大的功率比、功率级别以及温度指示了系统安全操作中导管能承受的最大限度。 Maximum power ratio, temperature and power level indicating a maximum safe operation of the catheter system can withstand.

[0072] 如上所述,操作者可以在步骤685中通过改变控制输入612的设置来改变设置点温度或温度范围、功率级别、频率以及消融时段。 [0072] As described above, the operator in the step 685 by changing the control input 612 is provided to change the set point temperature or temperature range, power level, ablation time and frequency. 操作者设定的温度设置输入可以是一个具体的温度或者温度范围。 The operator sets the temperature setting input may be a particular temperature or temperature range. 如果输入是一个具体的温度,系统将控制RF信号脉冲以使得检测温度等于由操作者选定的具体温度加上或减去几度。 If the input is a particular temperature, the control system so that the RF signal pulse detected temperature is equal to the operator selected by a particular temperature plus or minus a few degrees. 如果输入是温度范围,则系统控制RF 信号脉冲以使得检测的温度在选定范围之内。 If the input is a temperature range, the system controls the RF signal pulse so that the temperature detected within the selected range. 选定的设置点温度或温度范围可以在摄氏45度到摄氏125度的范围内,并且确切的温度设置将依赖于目标消融组织。 The selected set point temperature or temperature range may be in the range of 45 degrees Celsius to 125 degrees Celsius, and the precise temperature setting will depend on the target ablation tissue. 例如,在心脏, 温度设置或设置点可以在摄氏50到90度之间。 For example, in the heart, or set point temperature can be set between 50 to 90 degrees Celsius. 在非心内组织,例如肝脏,心脏的外表面, 或者其它非心内组织区域,温度设置或设置点可以在例如摄氏60到120度之间。 In the non-cardiac tissues such as the liver, the outer surface of the heart, or other non-cardiac tissue within the region, set temperature or set point may, for example, between 60 to 120 degrees Celsius. 出于为操作者参考的目的,该系统对于不同类型的生物组织具有推荐的温度级别或者范围。 For purposes of reference for the operator, the system having a recommended temperature level or range for different types of biological tissue. 在步骤695,微控制器将改变RF频率以获得并保持可能的最低反向/前向功率比,并在设置点上下调整RF功率级以获得等于或接近设置点的温度或者在设置点范围(其中温度设置是一个范围而不是具体温度)内的温度。 In step 695, the microcontroller changes the RF frequency in order to obtain and maintain the lowest possible reverse / forward power ratio, and adjusts the RF power level below the setpoint to achieve equal or close to the temperature set point or set point range ( wherein the temperature is set within a temperature range rather than a specific temperature). 同时,功率输出、温度和定时器都将被监视,并与设置值以及系统输出功率和过程温度的最大限度进行比较。 Meanwhile, the power output, the timer and the temperature will be monitored and compared with a set value and the output power of the system and the maximum process temperature.

[0073] 如上结合之前实施例的描述,对于组织消融所期望的是能够让传输线的阻抗尽可能的与负载阻抗匹配。 Before description of embodiments [0073] As described above with, for tissue ablation it is to allow a desired transmission line impedance and the load impedance as possible. 如果反向与前向功率比或者输入功率太高,这表示太多的能量被反射,例如,组织没有吸收,则调整信号频率以产生降低的功率比。 If the ratio or the input power to the high power of the reverse and the front, which means that too much energy is reflected, for example, tissue does not absorb, the frequency adjustment signal to produce a reduced power ratio. 由于在实际中无法实现理想的阻抗匹配,在步骤695中微控制器调节频率和功率级别,从而达到在选定消融温度设置点内限制的最低可能级另U。 Inability to achieve the desired impedance matching in practice, at step 695 the microcontroller adjusting the frequency and power level, so as to achieve the lowest possible level within a selected limit further the ablation temperature set point U. 如前述实施例中所示,可以设置比值的阈值,例如0.4:1,然后控制器可以调整频率直到比值降低到该阈值之下。 As shown in the previous embodiments, the threshold ratio may be set, for example, 0.4: 1, then the controller may adjust the frequency until the ratio decreased to below the threshold value. 在可选实施例中,如上所述,不使用功率比值,系统控制RF信号的频率和功率级别以维持选定的温度设置。 In an alternative embodiment, as described above, the power ratio is not used, the system frequency control and power level of the RF signal to maintain the selected temperature setting.

[0074] 在所描述的实施例中,改变RF频率和功率级别以获得尽可能接近选定温度设置点的温度,同时保持期望的反射与前向功率比值。 [0074] In the described embodiments, changing the RF frequency and power level to obtain a temperature close to the selected set point temperature as possible, while maintaining the desired ratio of reflected and forward power. 传感器510检测的温度将指示生物组织上的联合的RF能量影响。 Detected by the temperature sensor 510 will indicate the combined RF energy influence on biological tissue. 因此控制温度等于或者接近设置点将改善或优化组织消融。 Thus controlling the temperature set point is equal to or close to improve or optimize tissue ablation.

[0075] 如上所述,该系统对于功率比值、功率级别、温度级别有最大设置限度,如果超过了这些限度的任何一个,则消融过程停止(步骤700)。 [0075] As described above, the power ratio for the system, power levels, maximum temperature level-set limits, if any of these limits are exceeded, then the ablation process is stopped (step 700). 如果超过了其中一个最大限制值, 则关闭RF放大器并且消融过程停止(步骤665),并且在步骤670,该系统将显示和响起报警615。 Wherein if more than a maximum limit value, the RF amplifier is turned off and the ablation process is stopped (step 665), and in step 670, the system will display and alarm 615 sounds. 只要功率比值、功率级别以及温度在最大限度之内,消融过程就将在设置的时段内持续或者直到消融开关被操作者关闭(步骤710)。 As long as the power ratio, power level, and the maximum temperature in the ablation process will continue in the set period of time or until the operator closes ablation switch (step 710). 当消融时段结束或者操作者关闭消融开关,该系统将返回到步骤680,显示缺省或预先用户确定的消融参数并等待用户或操作者的进一步输入。 When the ablation period ends or operator closes ablation switch, the system returns to step 680, the display and wait for further user input ablation parameters or operator default or pre-determined by the user.

[0076] 在本实施例中,消融装置或导管配置有RF天线,为更精确控制,也为了降低温度过高或类似风险,该天线集成了温度传感系统。 [0076] In the present embodiment, the ablation device or catheter is configured with an RF antenna, a more precise control, but also to reduce the risk of overheating or the like, the temperature sensing system with integrated antenna. 通过控制反射/前向功率比以及反射组织温度,通过监视温度传感器的输出并改变功率级别以获得等于或者接近选定设置点的温度,从而最佳化传送到目标生物组织的RF能量。 Reflected by the front control / power ratio of the reflected tissue temperature, by monitoring the output of the temperature sensor and to obtain a change in the power level at or near the selected set point temperature, thereby optimizing the RF energy delivered to the target biological tissue. 有必要调整RF频率和信号功率级别以获得期望的生物组织作用,因此在消融过程控制中反射/前向功率比和检测的温度是互相依赖的。 Necessary to adjust the RF signal frequency and power level to achieve the desired biological tissue, and therefore ablation process control reflection / forward power ratio and the detected temperature are interdependent. 该反射功率反映了生物组织和天线系统作为整体的联合阻抗,因此最小化反射功率与前向功率的比值等同于系统阻抗匹配,该系统阻抗匹配最大化传送到待消融的生物组织的前向功率传递。 The biological tissue reflects the reflected power and combined antenna impedance as a whole system, thus minimizing the reflected power system impedance equal to the previous ratio of power to the system impedance to maximize the transfer of the biological tissue to be ablated forward power transfer. 温度传感器检测的温度改变可以与生物组织和天线系统作为整体的联合RF能量作用(消融)相关联,因此可以单独控制温度以获得期望的消融效果,必要时,可省略监视和控制反射/前向功率比的步骤。 Temperature changes temperature sensor may be combined RF energy effect of the entire biological tissue and antenna system as (ablation) is associated, so temperature can be controlled individually to obtain the desired ablation effect, if necessary, may be omitted to monitor and control the reflective / Forward step over power. 通过在预先设置的温度设置点之内建立测量的温度设置点并调整RF频率以及传送到目标组织的功率,将改善组织消融过程。 By establishing the set point temperature measured in the temperature set point set in advance and adjusting the RF frequency and the power delivered to the target tissue, will improve tissue ablation process. 在图6到8中描述的代表性实施例中,功率比值控制和温度控制的联合将增加消融系统的效力。 Representative described in FIGS. 6-8 embodiment, the power ratio and temperature control of the joint will increase the effectiveness of the ablation system.

[0077] 图7和8描述了控制系统和方法,其持续监视前向功率、反射功率以及温度,并结合接近的设置点温度来调整频率和功率级别,以获得并保持可能的最低反射/前向功率比。 [0077] FIGS. 7 and 8 describe the control system and method, before it continuously monitors the forward power, reflected power and temperature, and combined near the set point temperature to adjust the frequency and power level, in order to obtain and maintain the lowest possible reflection / front than to power. 频率和功率级别由微控制器设置,RF振荡器频率的固件调节和输出级别馈送至前置放大器模块618。 Frequency and power level provided by the microcontroller, RF oscillator frequency and adjusting the output level firmware is fed to a preamplifier module 618. 消融过程开始于频率和功率级别的缺省值,必要时频率和功率级别都可以进行调整以获得最低的反射/前向功率比,同时过程的温度接近温度设置点。 Default ablation procedure begins with the frequency and power level, if necessary, the frequency and power levels can be adjusted to obtain the lowest reflected power ratio to a / the front, while the temperature near the process temperature setpoint. 该系统也有独立于控制环的最大限度的功率比、功率级别以及温度,并且如果监视到超过这些值,则停止该过程并为用户报警。 The system also has a maximum power ratio, temperature and power level independent of the control loop, and if these values ​​are exceeded monitored, the process is stopped and an alarm for the user.

[0078] 该用于消融生物组织的基于射频的导管系统和方法可以用于多种医疗应用。 [0078] The biological tissue for ablating catheter-based systems and methods may be used for a variety of medical RF applications. 此处包含的说明书和附图描述了本发明的某些有代表性的实施例,因此,是被本发明广泛考虑的有代表性的主题。 The specification and drawings contained herein describe certain representative embodiments of the present invention, therefore, are representative of the subject matter broadly contemplated by the present invention. 本发明的范围完全包括了对于本领域技术人员而言显而易见的其它实施例,并且本发明的范围依据所附的权利要求进行限定。 Full scope of the invention include those of ordinary skill in the art that other embodiments apparent to, and the scope of the present invention are defined according to the appended claims.

Claims (26)

1. 一种用于生物组织消融的系统,包括:RF天线,其位于生物组织点附近;传输线,具有连接到所述RF天线的第一端,以及第二端;RF信号发生器,用于在所述传输线内产生一系列RF脉冲以传输到所述RF天线;与所述RF天线相连的温度传感器;控制器,其连接到所述RF信号发生器和所述温度传感器,所述控制器具有:配置为将温度传感器的检测温度与预设温度设置进行比较的温度控制模块,以及配置为调整所述RF信号直至所述检测温度尽可能接近所述预设温度设置的控制模块;以及RF信号检测器,耦合到所述传输线以检测所述RF脉冲的反射信号和前向信号,所述控制器包括配置为计算所述RF脉冲的检测到的反向信号与检测到的前向信号之比值的处理模块,所述控制模块进一步被配置为控制所述RF信号发生器以改变所述RF脉冲的频率从而使得所计算的比值改 CLAIMS 1. A system for biological tissue ablation, comprising: RF antenna, which is located near the point of biological tissue; transmission line having a first end and a second end connected to the RF antenna; RF signal generator is generated in the transmission line to transmit a series of RF pulses to said RF antenna; a temperature sensor coupled to said RF antenna; a controller, coupled to the RF signal generator and the temperature sensor, the controller comprising: a configured to detect the temperature sensor with a preset temperature setting of the temperature control module compares, and configured to adjust the RF signal until the detected temperature as close as possible to the predetermined temperature setting control module; and RF signal detector, coupled to the transmission line to detect the reflected RF pulse signal and the forward signal, the controller comprises a pulse is configured to calculate the detected RF reverse signal before the detected signals the ratio of the processing module, the control module is further configured to control the RF signal generator to vary the frequency of RF pulses so that the calculated ratio is changed ,直至所计算的比值低于预定门限,从而使得传输线阻抗基本与RF 天线和生物组织共同的联合负载阻抗匹配。 Until the calculated ratio is below a predetermined threshold, so that the transmission line impedance substantially common joint load impedance with the RF antenna and biological tissue.
2.如权利要求1所述的系统,其中所述控制模块被配置为控制所述RF信号发生器以改变所述RF能量脉冲的频率和功率级别,从而在保持所述检测温度至少接近所述预设温度设置时,保持所述计算的比值至少接近所述选定的比值。 2. The system according to claim 1, wherein the control module is configured to control the RF signal generator to vary the frequency of the pulses of RF energy and power level, thereby maintaining the detected temperature at least near the when the preset temperature setting, said selected ratio remains at least approximately the calculated ratio.
3.如权利要求2所述的系统,其中所述选定的比值为可实现的最低比值。 The system according to claim 2, wherein the selected ratio is the lowest ratio achievable.
4.如权利要求2所述的系统,其中所述选定的比值为预设的阈值。 4. The system according to claim 2, wherein the selected threshold is a preset ratio.
5.如权利要求1所述的系统,其中所述温度设置为温度范围。 5. The system according to claim 1, wherein said temperature range setting temperature.
6.如权利要求1所述的系统,其中所述温度设置是温度设置点加上或减去预定量。 6. The system according to claim 1, wherein said setting temperature is a temperature set point plus or minus a predetermined amount.
7.如权利要求1所述的系统,进一步包括连接到所述控制器的报警装置,所述控制器进一步包括报警模块,所述报警模块配置为将检测温度和预设最大温度进行比较,并且当所述检测温度高于所述预先设置的最大温度时启动该报警装置以产生报警。 7. The system according to claim 1, further comprising an alarm device coupled to the controller, the controller further comprises an alarm module, the alarm module is configured to detect a maximum temperature and a preset temperature are compared, and the alarm device is activated to produce an alarm when the detected temperature is higher than the preset maximum temperature.
8.如权利要求7所述的系统,其中所述控制器配置为当所述检测温度高于所述预设最大温度时,关闭所述RF信号发生器。 8. The system according to claim 7, wherein the controller is configured to, when the detected temperature is higher than the preset maximum temperature, closing the RF signal generator.
9.如权利要求7所述的系统,其中所述控制器配置为将检测功率级别与预设最大功率级别进行比较,并且当所述检测功率级别高于所述预设最大功率级别时,启动所述报警装置以产生报警,所述报警模块进一步配置为当所述功率级别超过所述预设最大功率级别时,关闭所述RF信号发生器。 9. The system according to claim 7, wherein the controller is configured to detect a power level and a preset maximum power level is compared, and when the detected power level is higher than the preset maximum power level, starting said alarm means to generate an alarm, the alarm module is further configured to, when the power level exceeds the predetermined maximum power level, turn off the RF signal generator.
10.如权利要求1所述的系统,进一步包括连接到所述控制器的用户输入模块,所述用户输入模块配置为由用户输入用户选定的参数。 10. The system according to claim 1, further comprising a user input module to the controller, the user input module is configured by the user to enter user-selected parameters.
11.如权利要求10所述的系统,其中所述用户选定的参数包括温度设置和RF信号功率级别,所述控制器进一步配置为在保持所述选定的温度设置时,保持所述RF信号尽可能接近用户选定的功率级别。 11. The system according to claim 10, wherein the parameters include user-selected temperature setting and an RF signal power level, the controller is further configured while maintaining the selected temperature setting, holding the RF signal as close to the user selected power level.
12.如权利要求11所述的系统,其中所述用户选定参数进一步包括消融时段。 12. The system of claim 11, wherein said user selected parameter further includes an ablation period.
13.如权利要求1所述的系统,其中所述RF天线是可弯曲的。 13. The system according to claim 1, wherein the RF antenna is bendable.
14.如权利要求1所述的系统,其中所述RF天线是可塑形的。 14. The system according to claim 1, wherein the RF antenna is shaping.
15.如权利要求1所述的系统,进一步包括将所述RF天线放置到所述生物组织负载的导管。 15. The system according to claim 1, further comprising placing the RF antenna to the biological tissue load duct.
16. 一种用于生物组织消融的系统,包括:RF信号模块,配置为产生一系列RF能量脉冲,在传输线内将所述一系列射频能量脉冲传送到设置在生物组织负载附近的RF天线;RF传感器模块,配置为当所述RF天线放置于所述待消融的生物组织附近时感应所述RF能量脉冲的反射信号和前向信号;温度传感器模块,配置为当所述RF天线放置于所述待消融的生物组织附近时检测温度;以及控制模块,其连接到所述RF信号模块、RF传感器模块以及温度传感器模块,所述控制模块被配置为调整所述一系列RF能量脉冲以保持反射功率与前向信号功率之比至少接近预定比值,并且保持检测的温度至少接近预选温度设置。 16. A system for biological tissue ablation, comprising: RF signal module, configured to generate a series of pulses of RF energy, the transmission line in the series of pulses of RF energy delivered to the RF antenna is provided in the vicinity of the biological tissue load; RF sensor module configured to, when the RF induction of the pulses of RF energy when the antenna is placed in the vicinity of the biological tissue to be ablated in the reflected signal and the forward signal; a temperature sensor module, configured to, when the RF antenna is placed in the near the detected temperature of said biological tissue to be ablated; and a control module connected to the RF signal module, sensor module and the RF module temperature sensor, the control module is configured to adjust said series of reflected pulses of RF energy in order to maintain access to the power ratio of the forward signal power is at least a predetermined ratio, and to maintain the detected temperature close to the temperature of at least a preselected set.
17.如权利要求16所述的系统,其中所述控制模块配置为确定所述传输线内的反射信号功率与前向信号功率的比值,并且所述预定比值是在保持检测温度至少接近所述选定温度设置时,可实现的最低的反射信号功率与前向信号功率之比值。 17. The system according to claim 16, wherein the control module is configured to determine that the reflected signal power in the transmission line and the ratio of the former to the signal power and said predetermined ratio is at least approximately at the selected holding temperature detecting when the predetermined temperature setting, the lowest reflected signal power can be achieved with a ratio of the former to the signal power.
18.如权利要求16所述的系统,其中所述控制模块配置为测量电压驻波比,并且所述预定比值为电压驻波比。 18. The system according to claim 16, wherein the control module is configured to measure the voltage standing wave ratio, and the ratio of the predetermined voltage standing wave ratio.
19.如权利要求16所述的系统,其中所述RF信号模块包括产生一系列RF脉冲的RF振荡器模块,以及连接到所述振荡器模块输出的放大器模块,所述放大器模块用于放大所述一系列RF能量脉冲,并且所述控制模块配置为控制所述振荡器模块和所述放大器模块以改变所述脉冲的频率和功率级别。 19. The system according to claim 16, wherein the RF signal generating module comprises a series of RF pulses RF oscillator module, and connected to said oscillator amplifier module output module, said amplifier means for amplifying the said series of pulses of RF energy, and the control module is configured to control the oscillator module and the amplifier module to change the frequency and power level of the pulse.
20.如权利要求16所述的系统,其中所述RF传感器模块包括采样所述前向信号和所述反射信号的双向信号检测模块。 20. The system according to claim 16, wherein the sensor module comprises sampling said RF forward signal and reflected signal of the bidirectional signal detection module.
21.如权利要求16所述的系统,进一步包括插入身体血管中的伸长的导管,所述导管具有与所述RF信号模块耦接的近端,包含位于选定的消融组织点附近的所述RF天线的远端部分,沿所述导管从所述近端延伸到所述RF天线的传输线,所述温度传感器模块包括位于所述导管的远端部分的温度传感器以及沿着所述导管从所述温度传感器延伸到所述近端的连接线,所述连接线连接到所述控制模块的温度传感器输入。 21. The system according to claim 16, further comprising inserting an elongated body vessel in a catheter having a proximal end coupled to the RF signal module, including the ablated tissue is located close to the selected point said distal end portion of the RF antenna along the conduit extending from the proximal end to the RF antenna transmission line, the temperature sensor module comprises a temperature sensor located at the distal end of the catheter and along the portion of the conduit from the temperature sensor extends into the proximal end of the connecting line, said input lines connected to a temperature sensor connected to the control module.
22.如权利要求16所述的系统,进一步包括连接到所述控制模块以接收来自用户的用户控制输入的用户输入模块。 22. The system according to claim 16, further comprising a user input module is connected to the control module to receive user input from a user control.
23.如权利要求16所述的系统,进一步包括报警模块,当检测到传感器的输出超过预定最大限度时所述报警模块提供报警输出。 23. The system according to claim 16, further comprising an alarm module, when the detected output of the sensor exceeds a predetermined maximum the alarm module provides an alarm output.
24. 一种用于生物组织消融的系统,包括:RF天线,其位于生物组织点附近;传输线,具有连接到所述RF天线的第一端,以及第二端;RF信号发生器,用于产生一系列RF脉冲,所述RF信号发生器具有耦接到所述传输线第二端的输出;RF信号检测器,其耦接到传输线以检测所述RF脉冲的反射信号和前向信号;以及控制器,其与所述RF信号发生器和所述RF信号检测器相连,并具有配置为计算所述检测的反射信号与所述检测的前向信号的电压驻波比的处理模块,以及具有控制模块,用于控制所述RF信号发生器以改变所述RF脉冲的频率直至所述计算的电压驻波比与选定的电压驻波比基本相应,其中所述选定的电压驻波比影响传输线阻抗与组织负载阻抗的基本匹配。 24. A system for biological tissue ablation, comprising: RF antenna, which is located near the point of biological tissue; transmission line having a first end connected to the RF antenna, and a second end; RF signal generator for generating a series of RF pulses, the RF signal generator having an output coupled to the second end of the transmission line; an RF signal detector coupled to a transmission line to detect the reflected RF pulse signal and the forward signal; and a control device, with the RF signal generator and a detector coupled to the RF signal, and configured to calculate a reflection signal having the detected processing module prior to said detected voltage standing wave ratio signal, and having a control means for controlling the RF signal generator to change the frequency of the RF pulses until said voltage standing wave ratio and calculating the voltage standing wave substantially corresponding to a selected ratio, wherein the selected ratio on the voltage standing wave transmission line impedance and load impedance substantially match tissue.
25.如权利要求M所述的系统,进一步包括与位于所述生物组织点附近的RF天线相连的温度传感器,所述控制器具有温度控制模块,所述温度控制模块配置为将所述温度传感器的检测温度和预设温度设置进行比较,所述控制模块进一步配置为调整所述RF信号直至检测的温度尽可能接近所述预设温度设置,同时保持所述计算的比值尽可能接近所述选定的比值。 M 25. The system of claim, further comprising a temperature sensor connected to the point located near the biological tissue RF antenna, said controller having a temperature control module, the module is configured to control the temperature of the temperature sensor the detected temperature and the preset temperature set by comparing the control module is further configured to adjust the temperature detected by the RF signal until the predetermined temperature is disposed as close as possible, while maintaining a ratio of said calculated as close as possible to the selected given ratio.
26.如权利要求对所述的系统,其中所述RF天线是可塑形天线以适应生物组织负载附近的身体血管的轮廓。 26. The system of claim, wherein said antenna is an RF antenna may be shaped to fit the contour of a body vessel near the biological tissue load.
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EP2034918A2 (en) 2009-03-18
EP2034918A4 (en) 2010-11-24
CN101484083A (en) 2009-07-15
HK1133169A1 (en) 2012-10-26
US20060287649A1 (en) 2006-12-21
US7594913B2 (en) 2009-09-29
WO2008005668A2 (en) 2008-01-10

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